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Trial record 3 of 8 for:    clear guide medical

Ultrasound-CT Fusion System for Interventional Radiology Procedures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03226535
Recruitment Status : Unknown
Verified July 2017 by Clear Guide Medical.
Recruitment status was:  Recruiting
First Posted : July 21, 2017
Last Update Posted : July 21, 2017
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Clear Guide Medical

Brief Summary:
The objective of this research is to use the Clear Guide SCENERGY technology, an FDA approved Ultrasound-CT fusion imaging system, that allows the user to fuse CT images onto a real-time ultrasound that is being performed on the patient. This fusion system will be used to perform ultrasound guided needle placements for patients undergoing percutaneous CT guided needle-based intervention. This study will consist of 20 patients, 10 patients using the CGM SCENERGY US-CT system and 10 patients using guidance only. The primary goal of the study is to prove that the new imaging fusion system is comparable to using either CT or US guidance alone to guide needle placement.

Condition or disease Intervention/treatment Phase
CT Guided Biopsy CT Guided Drain Placement Within the Abdomen or Pelvis CT Guided Injection of Muscle or Nerve Within the Pelvis Device: Ultrasound-CT Fusion Not Applicable

Detailed Description:

A simple 20 patient study will be performed using the CG SCENERGY system. This fusion system will be used to perform image guided needle placements for patients undergoing percutaneous CT guided needle-based intervention (CT guided biopsy, CT guided drain placement within the abdomen or pelvis, and CT guided injection of muscle or nerve within the pelvis). Only patients who are already scheduled for a CT guided procedure will be screened. The study design is as follows:

  • 10 patients will have their procedure performed using the CGM SCENERGY US-CT fusion system and 10 patients will have their procedure performed using CT guidance only.
  • Proper informed consent will be obtained
  • Perform a CT scan with the optical adhesive skin markers in place. Markers are placed around the expected site of needle skin entry.
  • The first 10 patients Group#1 (1-10) will be assigned to using the SCENERGY fusion system to complete the needle placement, and the next 10 patients Group #2 (11-20) will be assigned of continuing with CT guidance only to complete the needle placement.
  • If in Group #1, the procedure will proceed as usual using the SCENERGY system to guide the needle to target. If in the Group #2, CT guidance will be used to place the needle to target.
  • Once the needle is at the target, a confirmatory CT will be performed.

    • If the target is reached (i.e., the software directed the interventional radiologist to the right place, e.g. for correctly biopsying a lesion), the trial is considered a "success" and the procedure continues as normal.
    • If the needle is not in the right place, the trial is considered a "failure", and the procedure continues as normal without using the CGM software any further.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Ultrasound-CT Fusion System for Interventional Radiology Procedures
Actual Study Start Date : June 22, 2017
Estimated Primary Completion Date : June 22, 2018
Estimated Study Completion Date : June 22, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Ultrasound-CT Fusion Guidance
The participants in this group (test group) will utilize the ultrasound-CT fusion system for guiding needle placement.
Device: Ultrasound-CT Fusion
The Clear Guide SCENERGY is an Ultrasound-CT fusion device which supplements existing ultrasound and CT capabilities. The participants randomly selected (out of 20 patients) for use of the Clear Guide SCENERGY (test group) will receive ultrasound-CT fusion guidance from the MDs performing the procedure.
Other Name: Clear Guide SCENERGY

No Intervention: CT Guidance
The participants in this group (control group) will receive the procedure with traditional CT methods and equipment, for guiding needle placement.



Primary Outcome Measures :
  1. Number of CT scans or CT fluoroscopic images [ Time Frame: Immediately following intervention (within 2 hours) ]

Secondary Outcome Measures :
  1. Total procedure time [ Time Frame: Immediately following intervention (within 2 hours) ]
    Time from the first CT scan until the needle is at the target

  2. Time to target [ Time Frame: Immediately following intervention (within 2 hours) ]
    Time from needle entering the skin until the needle is at the target

  3. Success of needle placement [ Time Frame: Immediately following intervention (within 2 hours) ]
    A confirmatory CT will be performed to check if the needle reached the target



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing percutaneous CT guided needle-based intervention (CT guided biopsy, CT guided drain placement within the abdomen or pelvis, and CT guided injection of muscle or nerve within the pelvis)
  • Able to give written informed consent

Exclusion Criteria:

  • Unable to give informed consent
  • Patients undergoing CT guided needle-based interventions other than the procedures mentioned in the inclusion criteria
  • Prisoners, pregnant women, and children

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03226535


Contacts
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Contact: Brian Holly, MD 410-614-1622 bholly3@jhmi.edu
Contact: Taylor Dunklin, DA 410-502-5118 tdunkli1@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Brian Holly, MD    410-614-1622    bholly3@jhmi.edu   
Contact: Taylor Dunklin, DA    410-502-5118    tdunkli1@jhmi.edu   
Sub-Investigator: Douglas Yim, MD         
Sub-Investigator: Clifford Weiss, MD         
Principal Investigator: Brian Holly, MD         
Sub-Investigator: Taylor Dunklin, DA         
Sub-Investigator: Beatriz Kohler, RN, MBA, MPH         
Sponsors and Collaborators
Clear Guide Medical
Johns Hopkins University
Investigators
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Principal Investigator: Brian Holly, MD Johns Hopkins University
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Responsible Party: Clear Guide Medical
ClinicalTrials.gov Identifier: NCT03226535    
Other Study ID Numbers: CGM 17-001
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Clear Guide Medical:
Computer Assisted Instrument Guidance (CAIG)
Ultrasound-CT Fusion
Image Fusion
Clear Guide SCENERGY
Needle path
Needle Guidance
CT
Ultrasound